Prevention of Phantom Limb Pain After Transtibial Amputation

Brief Summary

Phantom limb pain following amputation is a major problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined. Objective: The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy. Study design: Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance. Main outcome of this study: Point prevalence of chronic phantom limb pain after 12 months.

Intervention / Treatment

  • Sciatic name block (PROCEDURE)
    Ultrasound-guided sciatic nerve block.

Condition or Disease

  • Phantom Limb Pain
  • Chronic Pain
  • Prevention

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 12 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2013 ACTUAL
    Primary Completion: Apr 01, 2017 ACTUAL
    Completion Date: Apr 01, 2017 ACTUAL
    Study First Posted: Jun 25, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 25, 2017

    Sponsors / Collaborators

    Responsible Party: N/A

    Rationale:

    Phantom limb pain following amputation is a major clinical problem. Current evidence how to best prevent phantom limb pain is equivocal because previous trials have included small numbers of patients, and tested heterogeneous patient collectives. There is some evidence that optimized perioperative pain control is effective in preventing phantom limb pain, but the potential added role of regional anesthesia has not been defined.

    Objective:

    The Aim of this study is to test the hypothesis that sciatic nerve block decreases the point prevalence of phantom limb pain 12 months after transtibial amputation for peripheral vascular disease compared to optimized intravenous pain therapy.

    Study design:

    Randomized, prospective, double-blind (patient, physician, statistician) clinical trial. All patients will receive standard optimized intravenous anesthesia and analgesia (opiate patient-controlled analgesia (PCA), intravenous ketamine). Patients in the intervention group will receive additional infusion of local anesthetic via a sciatic nerve catheter placed under ultrasound guidance.

    Study population:

    Patients undergoing elective transtibial amputation for peripheral vascular disease at one of the participating centres, ASA status II to IV.

    Intervention:

    Infusion of local anesthetic via sciatic nerve catheter placed under ultrasound guidance.

    Main study parameter/endpoint:

    Point prevalence of chronic phantom limb pain after 12 months.

    Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

    All patients, regardless of group allocation, will receive optimalized intravenous pain treatment. The aim of this study is to assess whether additional regional anesthesia (ultrasound-guided sciatic nerve block) can decrease the incidence of phantom limb pain. The working hypothesis is that patients undergoing intervention treatment (optimized intravenous therapy plus nerve block) are expected to feature a decreased incidence of phantom limb pain at 12 months, in addition to improved perioperative analgesia.

    The administration of both optimalized intravenous pain treatment and peripheral nerve blockade is routine clinical practice for many procedures on the lower leg, including amputation. The risk of this intervention can be described as very low. In control patients, the sciatic catheter will be used for rescue pain treatment.

    Participant Groups

    • Optimized intravenous pain treatment during surgery and for 7 days postoperatively. Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously. Sciatic nerve block: infusion of local anesthetic.

    • Optimized intravenous pain treatment during surgery and for 7 days postoperatively. Definition: strong opioid patient-controlled analgesia, non-opioids, ketamine intravenously. Sciatic nerve block: saline infusion.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * patients undergoing elective transtibial amputation for peripheral vascular disease
    * age over 18 years
    * American Society of Anaesthesiology status II to IV

    Exclusion Criteria:

    * contraindication to peripheral regional anesthesia
    * psychiatric disease
    * pregnancy or breastfeeding status
    * amputation for tumour surgery
    * traumatic amputation
    * inability to give written and informed consent.

    Primary Outcomes
    • Point prevalence of chronic phantom limb pain 12 months after amputation

    More Details

    NCT Number: NCT01626755
    Acronym: PLATA
    Other IDs: PLATA
    Study URL: https://clinicaltrials.gov/study/NCT01626755
    Last updated: Sep 29, 2023